Kornimate/medical-research-clean huggingface dataset:
camp air: efficacy and cost-effectiveness in urban adolescents

Conditions: Asthma

Summary: this study will test the efficacy and cost-effectiveness of controlling asthma program for adolescents (camp air), an e-health intervention, among urban predominately black and hispanic adolescents with uncontrolled asthma. it will also examine barriers and facilitators to adoption and implementation of camp air in high-schools.

asthma prevalence and morbidity are high among adolescents, especially among black and hispanic youth. yet, few interventions have been tested in adolescents. despite the important role that technology plays in the lives of adolescents, only one intervention for adolescents with asthma is web-based. additionally, research informing the scale-up of asthma interventions as well as their cost-effectiveness are scant. this study aims to address these treatment and methodological gaps by (1) systematically evaluating the efficacy of controlling asthma program for adolescents (camp air), an e-health intervention, in urban adolescents with uncontrolled asthma; (2) assessing camp air's cost-effectiveness; and (3) identifying multi-level factors associated with successful implementation of camp air to inform its future scale-up. due to covid, at the start of the study, the spirometry data will not be collected from the participants (secondary outcomes 7 - 9).

Eligibility criteria:
inclusion criteria: adolescents must report * a prior diagnosis of asthma; * asthma medication use in the last 12 months; and * symptoms consistent with uncontrolled asthma, defined as: in the last month (a) daytime symptoms 3+ days a week, (b) night awakenings 3+ nights per month, or (c) activity limitations 3+ days per week; or in the last 12 months (d) 2+ unscheduled visits to a clinic or medical provider because having asthma symptoms, (e) 2+ ed visits; (f) 1+ hospitalization for asthma, or (g) taken oral or systemic steroids in the past year. exclusion criteria: * pregnant teenagers due to the stress of adolescent pregnancy and hormonal changes of pregnancy that could change asthma control; * students enrolled in 12th grade because those randomized to the control group will not be in the school the following school year to receive camp air; * teenagers with a co-morbid disease or condition that might affect lung function, such as cystic fibrosis or sickle cell anemia; and * teenagers with highly specialized learning needs (e.g., down's syndrome, mental retardation, severe adhd) which may preclude completion of the intervention or assessments.

Keywords: adolescents e-health intervention cost-effectiveness
early-phase exercise-based cardiac rehabilitation after mi

Conditions: Myocardial Infarction (MI)

Summary: this study aimed to investigate the effects of early-phase exercise-based supervised cardiac rehabilitation on functional exercise capacity, grip strength, fatigue, sleep quality, and health-related quality of life.

myocardial infarction (mi) is not only a severe form of coronary heart disease but also a leading cause of death and physical disability, particularly in the rapidly growing elderly population. although percutaneous coronary interventions reduce mortality, ensuring the recovery and reintegration of discharged patients into society remains an unresolved issue. cardiac rehabilitation (cr) is beneficial for patients with mi in terms of reducing cardiovascular mortality and hospital readmissions, managing cardiovascular risk factors, and improving aerobic capacity. cr is a comprehensive intervention tailored to the individual needs of patients diagnosed with heart disease. it includes personalized exercise training, physical activity promotion, health education, cardiovascular risk management, and psychological support. initial recommendations for cr were limited to low-risk patients following mi. however, over the past two decades, with the accumulation of evidence supporting the benefits of cr, current clinical guidelines now routinely recommend comprehensive cr for a broader range of cardiac diagnoses, including acute coronary syndrome and heart failure with reduced ejection fraction. until two decades ago, studies recommended starting cr in the early phase, defined as the second-week post-discharge. however, in the past decade, cr initiation with very low-intensity exercise activity as early as one week after mi onset has been reported as safe and effective. more recently, studies have shown the beneficial effects of terminating bed rest within 12-24 hours and initiating bedside activities. phase i exercise-based cr has been shown to be effective in improving exercise capacity and preventing recurrent cardiac events. nonetheless, concerns remain regarding early exercise-based cr due to exercise-induced ischemia after acute mi. while the effects of early rehabilitation initiated post-mi have been investigated in the literature, sufficient evidence has yet to be established.

Eligibility criteria:
inclusion criteria: * clinically and medically stable patients with first mi * prescribed cardiac rehabilitation by a cardiologist * being between 30-65 years old * having ejection fraction (ef) of more than 20% (i.e. ef≥ 20%) * being volunteer to participate exclusion criteria: * having coronary artery bypass graft surgery * being diagnosed with chronic renal failure * presence of unstable angina * atrial fibrillation * severe and symptomatic aortic stenosis * presence of decompensated heart failure * exercise-induced myocardial ischemia, * pericardial disease, * moderate-to-severe valve disease * copd or asthma * bmi \> 40 kg/m2 * orthopedic and neurological problems that prevent exercise

Keywords: myocardial infraction mi early phase cardiac rehabilitation
comparison of the combination of fenofibrate and simvastatin versus atorvastatin

Conditions: Hyperlipidemia

Summary: mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. the overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


Eligibility criteria:
inclusion criteria: * mixed dyslipidemia. exclusion criteria: * known hypersensitivity to fenofibrates or simvastatin or atorvastatin * pregnant or lactating women * contra-indication to fenofibrate or simvastatin or atorvastatin * unstable or severe cardiac disease

Keywords: hyperlipidemia combined efficacy combination fenofibrate simvastatin versus atorvastatin
phase i/ii study of kp-100it in acute spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this study is randomized, double-blind, placebo-controlled phase i/ii study designed to evaluate safety and efficacy of kp-100it, code of hepatocyte growth factor (hgf) formulation for intrathecal injection, as a treatment for acute spinal cord injury. the study is conducted at two clinical sites in japan.


Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years and equal to or less than 75 years * cervical spinal cord injury, and grade a, b1 or b2 in the modified frankel scale at 72 hours since the injury * subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised exclusion criteria: * spinal cord injury at c1-c2 0r c2-c3 level * patients not to able to start rehabilitation within a week by setup of respirator or other reason * first dose of the study drug will not be given within 78 hours since the injury * history of spinal cord injury or abnormality in spinal cavity. or current considerable meningeal damage * outcome assessment will not be conducted adequately through damage on injuries other than the injury * high-dose steroid therapy within 30 days before the entry * patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections * history of malignant tumor * patients who participated in other clinical study within 30 days before the entry * patients who have allergies to drug scheduled to be used in the study * administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor * patients not able to understand "informed consent" properly * patients who are nursing or may be pregnant * investigator considers that the patient is not appropriate for participating in the study

Keywords: hepatocyte growth factor hgf kp-100it intrathecal injection
comparison of two methods of continuous positive airway pressure (cpap) to support successful extubation of infants of birth weights ≤ 1500 grams (c2cpap)

Conditions: Premature Birth; Respiratory Insufficiency

Summary: continuous positive airway pressure (cpap) has been used successfully to promote extubation in the premature infant population. the two methods of cpap to be examined are currently used by many institutions, yet no study has compared these methods to determine which is better in the population of newborns \ 65 mmhg or a sustained increase in fio2 of 0.15.

background: continuous positive airway pressure (cpap) has been used successfully to promote extubation in the premature infant population (davis \& henderson-smart, 2002). the two methods of cpap to be examined are used by many institutions, yet no study has compared these methods to determine which is better in the population of newborns \< 1500 grams (birth weight) at supporting extubation. this study may have cost savings implications. if bubble cpap is shown to be as effective in this application neonatal intensive care units (nicus) will have a more affordable option of providing effective cpap. methods: this randomised controlled, single site, clinical study is to determine if bubble cpap or infant flow system (ifs) cpap is more effective at supporting extubation in infants of birth weights \ 65 mmhg or a sustained increase in fio2 of 0.15. participants: parents/guardians of eligible infants will be approached and given information regarding the study, and any questions answered. they will then be allowed to consider study participation in private. the recruiter will return at an agreed time and informed consent will be obtained from those agreeing to participate. parents will be approached in accordance with the guidelines of the nicu @ swchsc. infants are eligible if birth weight \< 1500 grams, are to be extubated to cpap and have no known airway anomalies, or suspected genetic anomalies. analysis: multiple anova analysis will be used for continuous variables, chi-square for categorical variables, including primary outcome. conclusion: the results of this study will determine which method of cpap is the best method of supporting extubation in the \< 1500 g infant.

Eligibility criteria:
inclusion criteria: * intubated infant * ≤ 1500 grams at birth * decision to extubate to cpap made by the clinical team * written informed consent obtained exclusion criteria: * have known airway anomalies * have grade iii or iv or periventricular leukomalacia * have known or suspected genetic syndromes

Keywords: premature infant supporting extubation
multiple sclerosis and fatigue assessment

Conditions: Multiple Sclerosis

Summary: fatigue in patients with multiple sclerosis (ms) is a problem that is seen without physical exertion and affects the majority of patients. in studies on fatigue in the literature, it has been seen that subjective methods are frequently used by using evaluation scales based on patient statements, but objective evaluation methods are not yet sufficient. this study was planned to compare the measurement results by evaluating fatigue subjectively, objectively and cognitively in ms patients.

multiple sclerosis (ms) is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. it is characterized by clinical symptoms arising from lesions in the brain, spinal cord or optic nerves. although fatigue is one of the most common and most disabling problems of individuals with ms, it is not yet fully understood. this affects the treatment and disease process in ms. despite studies to elucidate the pathogenic mechanisms of fatigue, available information is limited. several factors contribute to the limited fatigue research, but the most important is that 'fatigue' is often not clearly defined or meaningful measures cannot be made in clinical/research settings. the first step in the evaluation of fatigue, which is a complex symptom, is to start with the identification and analysis of the factors that may cause fatigue, and to comprehensively question the factors that may be effective and the patient's history, and to evaluate the fatigue subjectively and objectively after the comprehensive patient history. the fatigue of patients diagnosed with ms will be evaluated subjectively, objectively and cognitively. other information about the disease of the patients will be recorded. subjective fatigue assessment methods, objective fatigue assessment methods and cognitive fatigue assessment methods will be applied.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * having a definite diagnosis of relapsing remitting ms by a neurologist, * expanded disability status scale (edss) score between 1-5.5, * to be stable in medical treatment, * being able to stand independently for at least 60 seconds without any assistive device, * it is to be above 24 points according to the mini-mental state examination (mmse) evaluation. exclusion criteria: * being diagnosed with ms for less than 1 year, * having had an ms attack in the last 3 months, * being illiterate or unable to communicate in turkish, * having an active infection, * being pregnant, * having an orthopedic problem or having a surgery that may affect the lower extremity, * having an additional neurological or circulatory disease that may cause balance disorder, a problem affecting the vision or vestibular tract, or a diagnosis of orthopedic surgery, rheumatological disease, * to be included in the physiotherapy and rehabilitation program in the last 3 months.

Keywords: multiple sclerosis fatigue assessment objective cognitive
spinal versus local anesthesia for hernia repair

Conditions: Hernia, Inguinal

Summary: patients underwent inguinal hernia repair; group a patients received subarachnoid anesthesia; group b patients underwent surgery with local anesthesia (mepivacaine 2%) performed by the surgeon; pain assessment was performed using a 0-10 numerical rating scale (nrs). intraoperative pain was assessed every 10 minutes,

all patients underwent inguinal hernia repair with the trabucco's technique (15), performed by the same surgical team. every patient was adequately informed of the procedural sequence of anesthesia and surgery and signed informed consent before being enrolled in the study. for both groups, patients received mild sedation with midazolam 0.03 mg/kg i.v.; paracetamol 1 gr and ketorolac 30 mg i.v. were given before surgery as multimodal pre-emptive analgesia. group a subarachnoid anesthesia was performed with a 27g whitacre needle at l2-l3 interspace, with patients on the lateral decubitus corresponding to the side of surgery. the introducer was inserted in the middle point of the space between two spinous processes, with a slightly cranial direction. the spinal needle was passed through the introducer and advanced till the subarachnoid space was reached, as confirmed by cerebrospinal fluid outflow. subsequently, 60 mg of prilocaine 2% were administered in the subarachnoid space, with a low-flow injection technique and the needle bevel turned laterally towards the sloping surgical side. lateral decubitus was maintained for at least 10 minutes (16). at 15 minutes from spinal anesthesia execution, and before surgery started, sensory and motor block were assessed by ice-test and numerical 0-3 bromage scale, respectively. group b patients underwent surgery with local anesthesia (mepivacaine 2%) performed by the surgeon before skin incision. further infiltrations of local anesthetic were ensured in case of pain during the surgery, for a maximum of 400 mg of mepivacaine. in case of uncontrolled pain, fentanyl 50 mcg i.v. was given for a maximum of two intraoperative administrations. if pain persisted, a deep sedation was performed with propofol continuous i.v. infusion. pain assessment was performed using a 0-10 numerical rating scale (nrs). intraoperative pain was assessed every 10 minutes,

Eligibility criteria:
inclusion criteria: indication for inguinal hernia repair; signed informed consent - exclusion criteria: neurological disorders; allergy to local anesthetics; liver disease; serious cardiac conduction problems; severe anemia; cardiogenic or hypovolemic shock; congenital or acquired methemoglobinemia; primitive changes in coagulation; patients treated with class iii antiarrhythmics (amiodarone); patients who did not suspend anticoagulants/antiplatelet agents; pregnant patients.

Keywords: subarachnoid anesthesia prilocaine
ahmed glaucoma valve implantation; graft-free short tunnel small flap versus scleral patch graft

Conditions: Glaucoma

Summary: glaucoma implants have been used for refractory glaucoma and are gaining popularity as a primary procedure in selected patients. in order to prevent tube erosion, a biologic material such as pericardium, cornea, and sclera is used as coverage over the tube. despite this preventive measures, patch graft thinning and silicon tube exposure are still a serious complications and may occur in 1%-7% of eyes after glaucoma implantation. in this study we used a novel technique named short tunnel small flap (stsf) by tunneling the sclera without using any biological material . efficacy and safety of this technique is comparing with conventional scleral patch graft. this randomized clinical trial, was performed at the glaucoma clinic of labbafinejad medical center, tehran, iran from september 2015 to january 2017 . the study was approved by the ethics committee at the ophthalmic research center, shahid beheshti university of medical sciences, tehran, iran and followed the tenets of the declaration of helsinki. after explaining all therapeutic options and their side effects, the written consent form was obtained from all patient. 80 eyes of 80 patients with refractory glaucoma underwent agv implantation by short tunnel small flap technique (group1) or scleral patch graft (group2) randomly. primary outcome measure is intraocular pressure(iop) and tube exposure, and secondary outcome measure is success rate that is defined as intraocular pressure (iop) \> 5 mmhg, ≤ 21 mmhg, and iop reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma. outcome measures are compared at 1, 3 , 6 and 12 months postoperatively.


Eligibility criteria:
inclusion criteria: * iranian patients with caucasian ethnicity, and at least 25 years old who had inadequately controlled glaucoma. exclusion criteria: * primary congenital glaucoma, thin sclera, no light perception vision, pregnant or nursing women, iridocorneal endothelial syndrome, epithelial or fibrous down growth, and unwillingness to participate in the study.
the multi-disciplinary treatment of functional gut disorders study

Conditions: Irritable Bowel Syndrome; Functional Dyspepsia; Constipation - Functional; Faecal Incontinence; Functional Abdominal Pain Syndrome; Other Rome IV Functional Gastrointestinal Disorders

Summary: randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.


Eligibility criteria:
inclusion criteria: * functional gastrointestinal disorder as defined by rome iv exclusion criteria: * diagnosed or suspicion of organic gastrointestinal disorder (ie coeliac, ibd) * age \ 80 * non-english speaking * patient's from outside of metropolitan melbourne who cannot attend clinic visits * prominent eating disorder * chronic opioid dependence * medications which can explain functional gut symptoms * surgery of gi tract that can explain functional gut symptoms * major, non-gi, organ dysfunction * pregnancy * major psychiatric disorder

Keywords: irritable bowel syndrome constipation functional dyspepsia multi-disciplinary treatment
a pilot pharmacokinetic phase i evaluation of bi-rg-587 in hiv-infected children

Conditions: HIV Infections

Summary: to generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (bi-rg-587) plasma levels in hiv-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in hiv-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in hiv-infected children. test tube studies have shown that nevirapine (bi-rg-587) inhibits replication (reproduction) of hiv. nevirapine works with zidovudine (azt) and is active against strains of the virus that are resistant to azt. studies of the drug in hiv-infected adults showed no serious adverse effects.

test tube studies have shown that nevirapine (bi-rg-587) inhibits replication (reproduction) of hiv. nevirapine works with zidovudine (azt) and is active against strains of the virus that are resistant to azt. studies of the drug in hiv-infected adults showed no serious adverse effects. two doses, given by mouth, are evaluated: three patients receive the lower dose, and 7 days after the third patient receives the lower dose, three additional patients receive the higher dose. after dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure blood levels of the drug.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * intravenous gammaglobulin. pneumocystis prophylaxis according to published guidelines. patients must have the following: * hiv infection. * parent or guardian must be available to give written informed consent. exclusion criteria concurrent medication: excluded: * zidovudine (azt). * steroid dependency. excluded within 1 hour before and 4 hours after study drug administration: * drugs that might interfere with the absorption of study drug (h2 blockers, antacids, carafate, cholestyramine). * benzodiazepines. * alcohol-containing substances. concurrent treatment: excluded: * requiring supplemental oxygen. patients with the following are excluded: * active opportunistic or serious bacterial infection. * lymphoid interstitial pneumonitis (lip) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 \< 70 mm hg. * pre-existing malignancies. prior medication: excluded: * zidovudine (azt) within 7 days prior to administration of study drug. excluded for at least 4 weeks prior to drug administration: * other approved or investigational antiretroviral agents. all other investigational agents. biologic response modifiers (e.g., interferon) or immunomodulators. immunosuppressive agents (including glucocorticoids). coumadin and other anticoagulant medications. prior treatment: excluded: * red blood cell transfusion within 4 weeks of study entry. patients may not have the following: * opportunistic or serious bacterial infection. zidovudine (azt) \> 7 days prior to administration of study drug. active alcohol or drug abuse.

Keywords: benzodiazepines drug evaluation drugs, investigational acquired immunodeficiency syndrome antiviral agents